D-1154-2022 Class II Terminated
FDA drug recall D-1154-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 10, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion The recall status is terminated (terminated Jul 25, 2023). Affected quantity: 47,500 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2022
- Initiation Date
- Jun 10, 2022
- Termination Date
- Jul 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47,500 vials
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Distribution Pattern
Nationwide within the United States
Code Information
Lot: HAC3427A, EXP Date: 08/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1154-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026